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505(b)(2) Combination Products

Posted by: Ken Phelps

Published on: May 8, 2009

During the Q&A after my audioconference yesterday a participant asked if a proposed drug product containing 1 new drug and 2 already approved drugs would be a 505(b)(2). Although she didn’t say so, I assumed that the 2 approved drugs did not belong to her company.

The answer is yes, the inclusion of these 2 already known and approved drugs into a new combination is submitted as a 505(b)(2). In my response to the question, I used the example of the antihistamine Allegra – D (came easily to mind, my allergies are terrible this season). The ‘D’ in the name stands for the decongestant pseudoephedrine HCl. The sponsor used 505(b)(2) to gain approval. Aventis owned the NDA for Allegra (fexofenadine HCl) but not for pseudoephedrine. Aventis used the 505(b)(2) route to submit the safety & efficacy information for pseudoephedrine. Similarly, Pfizer used the 505(b)(2) route for its approval of its antihistamine with pseudoephedrine, Zyrtec D.

Remember, a sponsor still must meet the criteria under the combination drugs 21 CFR 300.50 – showing, for example, the independent contribution of each drug substance to the clinical effect. The FDA has extensive information on combination products at this site.

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